Marine Protein Hydrolysate as Dietary Supplement in Elderly Part I

NCT03669796 | Completed

• 1 other identifier: 2017/1794
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to investigate the potential effect of a marine protein hydrolysate (MPH) supplement before a meal on postprandial glucose tolerance in healthy subjects, to achieve more knowledge on this presumed beneficial, blood glucose lowering effect

Conditions

Healthy Volunteers

Keywords

Dietary Supplements; Fish Proteins; Protein Hydrolysates; Aged

Outcome Measures

Primary Outcomes (1)

• Glucose

  Postprandial glucose (mmol/L) change on each day of intervention

  First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline.

Secondary Outcomes (4)

• Insulin

  First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline

• Hormon 1

  First sample fasting baseline, thereafter repeated samples (i.e.20, 40, 60, 100 minutes after baseline), last at 200 minutes after baseline

• Visual analogue scale (VAS)

  First (baseline) symptomscore (as described above) measured fasting , thereafter repeated symptom score i.e. at 20, 40 minutes after baseline, last symptom score measure at 200 minutes after baseline

• KANE, symptom score

  First (baseline) symptom score (as described above) measured fasting and the next measure at 200 minutes after baseline

Study Arms (2)

supplementary Marine protein hydrolysate

EXPERIMENTAL

20 mg powder per kg body weight of Marine protein hydrolysate (MPH)

Dietary Supplement: Marine protein hydrolysate (mph)

control

PLACEBO COMPARATOR

20 mg powder per kg body weight of casein/maltodextrin

Dietary Supplement: Control

Interventions

Marine protein hydrolysate (mph) DIETARY_SUPPLEMENT

Marine (Cod) protein hydrolysate

supplementary Marine protein hydrolysate

Control DIETARY_SUPPLEMENT

Maltodextrin/Casein

control

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Body mass index (BMI) 20-30

You may not qualify if:

• Suspected allergies against fish or shellfish
• Low or unstable blood pressure
• Diabetes mellitus, treated pharmacological
• Chronic diseases or therapies that is likely to interfere with the evaluation of study results
• Allergic to milk, confirmed diagnose
• Pregnancy
• Women who are breast-feeding infants
• Inability or unwillingness to comply with the requirements of study procedures

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead
• Haukeland University Hospital: collaborator

Study Sites (2)

Ålesund Hospital, Helse Møre og Romsdal HF

Ålesund, Norway

Location

Haukeland University Hospital

Bergen, Norway

Location

Related Publications (3)

• Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Bronstad I, Lihaug Hoff DA, Lied GA. Effect of a cod protein hydrolysate on postprandial glucose metabolism in healthy subjects: a double-blind cross-over trial. J Nutr Sci. 2018 Nov 28;7:e33. doi: 10.1017/jns.2018.23. eCollection 2018.

  PMID: 30524707 RESULT

• Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Bronstad I, Hoff DAL, Lied GA. Erratum: Effect of a cod protein hydrolysate on postprandial glucose metabolism in healthy subjects: a double-blind cross-over trial - CORRIGENDUM. J Nutr Sci. 2019 Jan 18;8:e1. doi: 10.1017/jns.2018.30. eCollection 2019.

  PMID: 30719283 RESULT

• Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Bronstad I, Hoff DAL, Lied GA. Acute effect of a cod protein hydrolysate on postprandial acylated ghrelin concentration and sensations associated with appetite in healthy subjects: a double-blind crossover trial. Food Nutr Res. 2019 Oct 22;63. doi: 10.29219/fnr.v63.3507. eCollection 2019.

  PMID: 31692759 RESULT

MeSH Terms

Interventions

5,10-dihydro-5-methylphenazine

Study Officials

• Dag Arne Lihaug Hoff, MD, PhD

  Møre & Romsdal Hospital Trust, Ålesund Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A double-blind crossover trial, including two different study days, with 4-7 days wash-out (WO) period in between. The intervention implemented 20 mg of MPH per kg body weight (test material) or control (casein).

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: September 13, 2018
• Study Start: November 27, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: November 14, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)